Weighted Blankets for Sleep Disturbance Among Children With ADHD

University Hospital Bispebjerg and Frederiksberg

Status: Enrolling

Conditions: Attention-Deficit Hyperactivity Disorder, Unspecified Type; Attention Deficit Disorder; Attention Deficit Hyperactivity Disorder; Attention-deficit Hyperactivity; Neurodevelopmental Disorders; Hyperkinetic Conduct Disorder; Sleep Disturbance

Treatments: Device: Non-weighted blanket; Device: Weighted blanket

Study type: Interventional

Funder types: Other

Identifiers

NCT06194162

Sweet Dreams

Details and patient eligibility

About

Many children with ADHD suffer from sleep disorders and dysfunction, which may affect development and well-being. According to the clinicians, some children find relief from restlessness and difficulty sleeping by using weighted blankets which have been proposed to reduce restlessness and stress via sensory integration and to calm the child by stimulating the sense of touch, muscles and joints. However, evidence for an effect on sleep is scarce, and only one RCT has investigated the effect of weighted blankets among children with ADHD. Using a RCT design, the aim is to investigate the effect on sleep disorders and dysfunction in children with ADHD aged 5-12 years by (1) using a weighted blanket during night and daytime in addition to usual treatment, compared to (2) usual treatment and a non-weighted sham blanket, with the primary outcome being differences in total sleep time. Results will support health- and social professionals who are involved in the treatment of children with ADHD.

Full description

Over the past decade, interest in the relationship between sleep difficulties and ADHD has increased, with evidence showing that sleep problems are very common among school children with ADHD, affecting nearly three-quarters. Sleep problems may worsening daytime behaviors and may also affect the overall wellbeing of the family, leading to poorer parental mental health and higher stress. According to the clinicians, some children find relief from restlessness and difficulty sleeping by using weighted blankets which have been proposed to reduce restlessness and stress via sensory integration and to calm the child by stimulating the sense of touch, muscles and joints. However, evidence for an effect on sleep is scarce, and only one RCT has investigated the effect of weighted blankets among children with ADHD. Using a RCT design, the aim is to investigate the effect on sleep disorders and dysfunction in children with ADHD aged 5-12 years by (1) using a weighted blanket during night and daytime in addition to usual treatment, compared to (2) usual treatment and a non-weighted sham blanket, with the primary outcome being differences in total sleep time.

The study is designed as a superiority trial: a parallel group, randomised controlled trial, where participants are randomised to one of two study arms 1:1. The sample consists of 340 participants, divided into two groups. After randomisation each participant will stay in their assigned treatment arm during the entire study. For each study participant, the active intervention period is 28 days with assessment of primary and secondary outcomes at baseline and after 28 days of intervention. Thereafter participants will be followed through national health registers.

The trial will take place at the Child and Adolescent Mental Health Center, Mental Health Services in the Capital Region of Denmark. This center is providing assessment and treatment of children and adolescents with psychiatric disorders.

Enrollment: 340 estimated patients

Sex: All

Ages: 5 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Signed informed consent.
2. Age 5-12 years (both included) at randomization.
3. Primary diagnosis of ADHD according to ICD-10 code F90.0, F90.1, F90.9 or F98.8.
4. Comorbidities are allowed.
5. Participated in a usual care sleep hygiene program managed by clinicians without effect within 6 months prior to enrollment.
6. If on ADHD medication or/and melatonin/sleep medication the dose must be stable, at least two weeks prior to enrollment.
7. The child and caregiver have adequate mastery of the Danish language.

Exclusion criteria

1. Have used any type of medical device class 1 weighted blanket before.
2. Any diagnosed diseases that markedly compromises the participant's ability to adhere to the intervention (like mental retardation, severe underweight, chronic respiratory or circulatory conditions, surgical implants, osteoporosis).
3. Another member of the household enrolled in the trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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340 participants in 2 patient groups

Weighted blanket

Experimental group

Description:

The intervention group will receive a weighted blanket classified as a medical device class 1 as an add on to usual treatment.

Treatment:

Device: Weighted blanket

Non-weighted blanket

Sham Comparator group

Description:

The control comparator group will receive a sham intervention in the form of a non-weighted blanket. as an add on to usual treatment.

Treatment:

Device: Non-weighted blanket